Hydralazine Hydrochloride

ANDA 40858, held by Heritage Pharms Inc. Hydralazine Hydrochloride.

As of Nov 15, 2026, ANDA 40858 (Hydralazine Hydrochloride), held by Heritage Pharms Inc, was first approved by FDA on Feb 26, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 26, 2010
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 26, 2010	Original application	Approved	None posted

Products

4 strengths and forms


Hydralazine Hydrochloride10MG · tablet;oral	Hydralazine Hydrochloride	Rx
Hydralazine Hydrochloride25MG · tablet;oral	Hydralazine Hydrochloride	Rx
Hydralazine Hydrochloride50MG · tablet;oral	Hydralazine Hydrochloride	Rx
Hydralazine Hydrochloride100MG · tablet;oral	Hydralazine Hydrochloride	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 6, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Feb 26, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 40858
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters